Patient comfort and safety in CECT imaging of abdomen/pelvis

• Research type

  Research Study

• Full title

  A phase 4 randomized, double-blind study comparing patient comfort and safety between Iodixanol 320mg I/ml and Iopamidol 370mg I/ml in patients undergoing contrast-enhanced computed tomographic (CECT) imaging of the abdomen/pelvis

• IRAS ID

  74184

• Contact name

  Ian McCafferty

• Sponsor organisation

  GE Healthcare

• Eudract number

  2011-000050-32

• ISRCTN Number

  N/A

• Research summary

  Patient discomfort from contrast media (CM) administration is a common concern for both patients and referring physicians. It may also contribute to poorer image quality due to patient movement. To date, there are no patient comfort data available comparing iodixanol with a commonly used LOCM, iopamidol in CT. The main aim of this study is to compare the overall patient comfort profile between these 2 CMs for patients undergoing CECT imaging of the abdomen/pelvis. Patient discomfort is defined as a sensation of coldness, heat and/or pain experienced by the patient due to the administration of the contrast medium. This study will also compare the impact of patient discomfort on the image procedure and image quality; and compare the safety profile in terms of adverse events.Participants will undergo CECT imaging of the abdomen/pelvis as part of their routine medical care. They will be randomized to receive either iodixanol or iopamidol. The presence or absence of patient discomfort in terms of sensation of coldness, heat or pain will be assessed immediately following the CT procedure and recorded. The patient will report verbally their discomfort on a scale of 0 to 10. The CECT image will be assessed and the overall image quality will be graded on a scale of excellent, adequate or poor depending on the amount of movement by the patient during the imaging process. Poor scans will be repeated. The participants will be followed up by a phone call 24 hours later to see if they have had any changes in medications or experienced other side effects from the CM.

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  11/WM/0068

• Date of REC Opinion

  12 May 2011

• REC opinion

  Further Information Favourable Opinion